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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Obstetric (And Accessories)
510(k) Number K861030
Device Name LABOR-DELIVERY STRETCH/BED
Applicant
Adel Medical , Ltd.
16700 SE 120th Ave.
P.O. Box 542
Clackamas,  OR  97015
Applicant Contact DAVE COLE
Correspondent
Adel Medical , Ltd.
16700 SE 120th Ave.
P.O. Box 542
Clackamas,  OR  97015
Correspondent Contact DAVE COLE
Regulation Number884.4900
Classification Product Code
KNC  
Date Received03/18/1986
Decision Date 04/23/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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